[Translation] A randomized, open-label, single-dose, four-period, two-sequence, completely repeated crossover bioequivalence study of bromocriptine mesylate tablets in healthy subjects under the fed state
1、主要研究目的:研究餐后状态下单次口服受试制剂甲磺酸溴隐亭片(规格:2.5mg,浙江泰利森药业有限公司)与参比制剂甲磺酸溴隐亭片(商品名:Parlodel®,规格:2.5mg;DOPPEL Farmaceutici S.r.l.公司生产)在健康成年受试者体内的药代动力学,评价餐后状态口服两种制剂的生物等效性。
2、次要研究目的:研究受试制剂甲磺酸溴隐亭片和参比制剂甲磺酸溴隐亭片(Parlodel®)在健康成年受试者中的安全性。
[Translation] 1. Main study objectives: To study the pharmacokinetics of the test preparation bromocriptine mesylate tablets (specification: 2.5 mg, Zhejiang Tailisen Pharmaceutical Co., Ltd.) and the reference preparation bromocriptine mesylate tablets (trade name: Parlodel®, specification: 2.5 mg; produced by DOPPEL Farmaceutici S.r.l.) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state.
2. Secondary study objectives: To study the safety of the test preparation bromocriptine mesylate tablets and the reference preparation bromocriptine mesylate tablets (Parlodel®) in healthy adult subjects.